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Reference materials for microbiology and pathogens

The regular occurrence of food borne pathogen related outbreaks in the EU, the ongoing struggle with pathogens in health care and public health as well as the security threat related to the potential misuse of pathogens emphasise the need for an adequate and reliable monitoring system and preparedness against these risks. Consequently the JRC is aiming at maintaining a high level of quality of the measurements which have to be carried out in this context by developing and providing suitable quality assurance tools, such as reference materials, and measurement techniques.  

The implementation of the regulation on microbiological criteria for food stuffs related legislation in the 'hygiene package' is based on the availability of adequately performing pathogen detection methods. To ensure proper performance of the detection methods laboratories are expected to implement quality assurance systems and to validate the performance of their detection methods with appropriate reference materials. Therefore the JRC has developed and will also develop in the future well characterised reference materials containing known numbers of microorganisms and covering those pathogens which are the origin of the majority of food borne outbreaks.

In the health area pathogen detection is carried out for screening the safety of medical products, in particular blood products, in transplantation medicine and disease diagnosis. Assays used in for laboratory medicine purposes have to fulfil the requirements laid down in In Vitro Diagnostics – Medical Device Directive in order to make sure that their performance is adequate. The performance is assessed amongst others by using reference materials. In order to improve the efficiency of the performance assessment as well as to maintain an adequate performance level over long time, the JRC has joint the INFECT-MET consortium. The INFECT-MET project is run under the European Measurement Research Programme (EMRP) and is aiming at the provision of improved methods and quality assurance tools for monitoring infectious diseases, antimicrobial resistance and harmful microorganisms related to respiratory diseases.

The natural risks but also the risks related to potential misuse of pathogens and toxic compounds formed by microorganisms requires an adequate level of preparedness of relevant authorities and institutions in the EU States. In 2009 the European Commission provided an action plan (Communication from the Commission to the European Parliament and the Council of 24 June 2009 on strengthening Chemical, Biological, Radiological and Nuclear Security in the European Union – an EU CBRN Action Plan), to maintain the necessary level of preparedness or to raise it where necessary. In view of a potential misuse of biological toxins and in line with the CBRN Action Plan, it is important that national experts agree on similar standards, harmonise their analytic approaches and exchange knowledge and technologies. With these aims the EQuATox consortium has been established in which the JRC is a partner.